What are the responsibilities and job description for the QC Analyst position at CSL Seqirus?
Entity: CSL Seqirus
Job Category: Quality
Job Family: Quality Control
Job Type: Full Time
Location: Holly Springs, North Carolina, United States
Employer Reference: R-273603
Job Description
The Opportunity
Your responsibilities for this position include performing tasks associated with release testing and reviewing laboratory data. The incumbent will ensure that Seqirus samples are collected, tested, and reviewed according to quality requirements. Additionally, you will ensure results are valid, accurate, and documented per applicable regulatory and corporate requirements.
SHIFT: Days – Monday – Friday (Some flexibility for nights and weekends)
HOURS: (8 am – 5 pm)
CORE HOURS: (9 am – 2 pm)
(Shift flexibility is open)
The Role
Performs testing and associated tasks without errors per applicable SOPs and protocols within Immunology/Biochemistry function.Complies with policies and procedures to maintain compliance with legal regulations, health and safety, and regulatory requirements as written.
Participates in lean lab operation, 6S laboratory layout, preventive action & continuous improvement programs to reduce operating costs.
Participates and performs cross-training to support staff availability within the QC department.
Develops and maintains SOPs.
Develops expertise in assigned assays/techniques.
Authors deviation and invalid assay assessments.
May be required to perform additional shift work as required to support operations.
Bachelor's degree in science or engineering discipline. An advanced degree is a plus.Bachelor’s degree in Molecular Biology, Biochemistry, Chemistry, or equivalent preferred.
Minimum of 1-5 years of laboratory experience OR equivalent.
One (1) year of GMPs, safety regulations, and data integrity preferred.
Experience performing essential biochemistry/molecular biology-based assays FTIR, UV-VIS, ELISA, or SDS-PAGE is preferred.
Knowledge of analytical methods and related instrumentation.
Knowledge of aseptic technique preferred.
LIMS experience preferred.
Benefits: Medical, Dental, Vision, Life Insurance, 401K, and PTO available from your first day of hire.
About CSL Seqirus
CSL Seqirus is part of CSL. As one of the largest influenza vaccine providers in the world, CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S., the U.K. and Australia, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at CSL
At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.
To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
Equal Opportunity Employer
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.